FDA recall Z-0250-2020
Cordis Corporation · Class II · device
Product
Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Reason for recall
Product was manufactured utilizing an expired inner body.
Distribution
US distribution to AL, AZ, FL, MN, and MO
Key facts
- Status
- Terminated
- Initiation date
- 2019-10-04
- Report date
- 2019-11-06
- Termination date
- 2020-12-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Miami Lakes, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0250-2020